| Company* (Country; Symbol) |
Product | Description | Indication | Status (Date) |
| AUTOIMMUNE | ||||
| BioMarin Pharmaceuticals Inc. (BMRN) and La Jolla Pharmaceutical Co. (LJPC) | Riquent | Abetimus sodium | Systemic lupus erythematosus | Companies are stopping their Phase III trial after the first interim efficacy analysis determined it would be futile to continue (2/12) |
| MAP Pharmaceuticals Inc. (MAPP) | Budesonide | Nebulized version | Asthma | It did not improve symptoms any better than placebo in a Phase III study (2/24) |
| CANCER | ||||
| Algeta ASA (Norway; OSLO: ALGETA) | Alpharadin | Alpha emitter | Bone metastases in hormone-refractory prostate cancer | Company will enroll U.S. patients in a Phase III trial (2/3) |
| Bradmer Pharmaceuticals Inc. (Canada; TSX:BMR) | Neuradiab | A monoclonal antibody designed to target tenascin | Brain cancer | Company said site initiation delays would prevent it from completing enrollment in an ongoing Phase III trial (2/17) |
| Celgene International Sarl (Switzerland; CELG) | Vidaza | Azacitidine | Myelodysplatic syndromes | Phase III data indicated that Vidaza demonstrated a significant extension of overall survival compared to conventional care regimens (2/18) |
| Cell Genesys Inc. (CEGE) | GVAX | Immunotherapy | Prostate cancer | Further data from its terminated Phase III trial showed a late favorable effect on patient survival compared to chemotherapy; data from a second Phase III trial showed no significant toxicities in the GVAX plus Taxotere arm that could explain an imbalance in deaths (2/27) |
|
Cell Therapeutics Inc. (CTIC) |
Pixantrone | An anthracenedione | Non-Hodgkin's lymphoma | Phase III data supported a robust clinical benefit for pixantrone when used as single agent therapy (2/18) |
| Cougar Biotechnology Inc. (CGRB) | CB7630 | Abiraterone acetate | Prostate cancer | Reached agreement with the FDA under an SPA for a Phase III trial (2/10) |
| Genentech Inc. (NYSE:DNA) and OSI Pharmaceuticals Inc. (OSIP) | Avastin; Tarceva | VEGF-inhibitor, bevacizumab; and EGFR inhibitor, erlotinib | Non-small-cell lung cancer | Phase III data showed a significant improvement in progression-free survival with the combination therapy (2/3) |
| GPC Biotech AG (Germany; FSE:GPC) | Satraplatin | Platinum agent shown to work via targeting the DNA in tumor cells | Prostate cancer | Phase III data showed it warrants additional testing in docetaxel-refractory patients (2/27) |
| ImClone Systems (subsidiary of Eli Lilly and Co.) andGenentech Inc. (NYSE:DNA) | Erbitux and Avastin | Cetuximab and bevacizumab | First-line metastatic colorectal cancer | Phase III data in CAIRO2 found that the addition of Erbitux to Avastin and the chemotherapy drugs capecitabine and oxaliplatin decreased progression-free survival and quality of life while increasing adverse events (2/5) |
| Pfizer Inc. | Axitinib | An oral inhibitor of vascular endothelial growth factor receptors 1, 2 and 3 | Advanced pancreatic cancer | Discontinued its Phase III trial after an interim analysis found no evidence of improvement in the primary endpoint of survival in patients treated with axitinib plus gemcitabine vs. gemcitabine alone (2/2) |
| Seattle Genetics Inc. (SGEN) | SGN-35 | Antibody-drug conjugate comprising an anti-CD30 antibody attached by an enzyme cleavable linker to a potent, synthetic drug payload, monomethyl auristatin E | Hodgkin's lymphoma | Started a pivotal trial (2/19) |
| Synta Pharmaceuticals Corp. (SNTA) | Elesclomol | An oxidative stress inducer | Metastatic melanoma | Met its target of 630 patients for a pivotal Phase III study, the SYMMETRYSM trial (2/2); company halted development due to a higher than expected death rate (2/27) |
| CARDIOVASCULAR | ||||
| Chelsea Therapeutics International Ltd. (CHTP) | Droxidopa | A synthetic precursor to norepinephrine | Neurogenic orthostatic hypotension | Phase III data demonstrated a robust reduction in the severity of symptoms and an improvement in standing systolic blood pressure (2/17) |
| Cordex Pharma Inc. (OTC BB: CDXP) | ATPace | A stable formulation of adenosine 5'- triphosphate | PSVT | Submitted an amended trial protocol for a pivotal study in response to FDA comments on he initial SPA submission (2/18) |
| InterMune Inc. (ITMN) | Pirfenidone | Inhibits collagen synthesis, down-regulates pro-fibrotic cytokines, blocks tumor necrosis factor-alpha synthesis and decreases fibroblast proliferation | Idiopathic pulmonary fibrosis | Phase III trials, CAPACITY 1 and CAPACITY 2, showed an overall positive treatment effect, but only the second one demonstrated statistical significance (2/3) |
| CENTRAL NERVOUS SYSTEM | ||||
|
Cerimon Pharmaceuticals Inc.* |
Diclofenac | Sodium patch | Acute pain | Enrolled its first subjects in a Phase III program (2/25) |
| CytRx Corp. (CYTR) | Arimoclomol | Molecular chaperone amplifier | Amyotrophic lateral sclerosis | Company is moving into a Phase II/III trial in a small subset of patients (2/23) |
| Neuropharm Group plc (UK; AIM:NPH) | NPL-2008 | A melt-in-the-mouth formulation of the selective serotonin reuptake inhibitor fluoxetine | Autism | Phase III failed to significantly reduce repetitive behaviors in autistic patients compared to placebo (2/18) |
| Newron Pharmaceuticals SpA (SWX:NWRN) and Merck Serono (Switzerland) | Safinamide | An add-on treatment to dopamine agonist therapy | Parkinson's disease | Phase III data showed it met its primary endpoint by increasing daily "on" time (2/3) |
| Pfizer Inc. | PD 332,334 | Alpha-2 delta ligand | Generalized anxiety disorder | Terminated the Phase III program because data showed it would not offer significant improvement over the standard of care (2/25) |
| DIABETES | ||||
| Human Genome Sciences Inc. (HGSI) and GlaxoSmithKline plc (UK) | Syncria | Albiglutide | Type II diabetes | Started a Phase III trial (2/17) |
| Indevus Pharmaceuticals Inc. (IDEV) | PRO 2000 | A vaginal microbicide | To prevent HIV | Data showed that women who received PRO 2000 had an approximately 30% lower risk of acquiring HIV infection than women who received a placebo or no vaginal product (2/9) |
| Optimer Pharmaceuticals Inc. (OPTR) | Prulifloxacin | Once-daily (600 mg) oral therapy | Travelers' diarrhea | Phase III data showed it met the study objective of superiority to placebo in the resolution of diarrhea (2/24) |
| Vertex Pharmaceuticals Inc. (VRTX) | Telaprevir | Protease inhibitor | Hepatitis C | Completed dosing in the Phase III ADVANCE trial, and completed enrollment in the REALIZE and ILLUMINATE Phase III trials (2/10) |
| ViroPharma Inc. (VPHM) | Maribavir | Antiviral drug | To prevent cytomegalo-virus | Failed to meet its primary end-point of preventing cytomegalo-virus disease in a Phase III trial in patients undergoing stem cell transplant (2/9); company discontinued its Phase III trial (2/13) |
| MISCELLANEOUS | ||||
| Orthogen AG* (Germany) | Orthokine | Endogenous protective proteins produced using the Orthokine procedure | Osteoarthritis of the knee | Patients experienced statistically significantly less pain and had more improved joint function than those who receive hyaluronic acid or p lacebo (2/23) |
| Pfizer Inc. | Esreboxetine | Norepinephrine reuptake inhibitor | Fibromyalgia | Terminated the Phase III program because data showed it would not offer significant improvement over the standard of care (2/25) |
| Vivus Inc. (VVUS) | Avanafil | A fast-acting, selective, oral phosphodiesterase Type 5 inhibitor | Erectile dysfunction | Started its second Phase III trial (2/10) |
|
Notes: * Privately held. SPA = Special protocol assessment.Unless otherwise noted, the stock symbols listed for public companies are on the Nasdaq market. AIM = Alternative Investment Market; FSE = Frankfurt Stock Exchange; NYSE = New York Stock Exchange; OTC BB = Over-the-Counter Bulletin Board; SWX = Swiss Stock Exchange; TSX = Toronto Stock Exchange. | ||||
